The importance of addressing ethics in your research or innovation project
MSF Scientific Days seek to showcase research that has been carried out according to the highest possible ethical standards. Preserving and enhancing the wellbeing of the communities served by MSF must be the overarching imperative of any research, which is why all MSF researchers should be familiar with the MSF research ethics framework. Independent ethical review by the MSF Ethics Review Board (ERB) is essential to achieving this aim, and therefore all research involving human subjects must be submitted to ethics review.
Research can be exempted from ERB review under certain conditions:
Analysis of routinely collected clinical data does not require ERB review if the medical directors take responsibility for addressing the ethics issues. The following criteria must be fulfilled to qualify for exemption from ERB review:
- Studies/articles are based on routinely-collected programme data.
- They are either descriptive/evaluative or targeted evaluations.
- Confidentiality is respected; no individual patient identifiers are revealed.
- Harm is minimal but acknowledged where relevant.
- Potential benefits to both the programme and the community are described. Since the goal is publication, the relevance to a wider audience is considered.
- Collaborative involvement and, if applicable, authorship from a local authority or partner (Ministry of Health, DHO, other NGO) is encouraged. If relevant and possible, consultation with a body representing the community is desirable.
- If the decision for exemption from review is taken by the medical directors, the responsibility to ensure that ethical requirements are met lies with MSF. This, however, does not exempt MSF from complying with regulatory requirements in the country where the data originated. In some countries, local ethical review may still be required.
Research involving human participants, including use of their data, requires approval by the MSF Ethics Review Board (ERB) and, similarly, innovation projects that constitute medical research (i.e. involving human participants or their data) should follow the research ethics review process. However, innovation projects can involve ethical risks and have consequences for populations even if human participants are not directly involved. Therefore the Project Sponsor (or whoever is responsible for oversight of the initiative) should consult the MSF innovation ethics framework to ensure that their project is ethically sound.
When to seek further advice on ethics
If you can answer ‘yes’ to any of the following questions, we suggest you seek advice on whether your project requires ethical evaluation:
- Does your project involve vulnerable participants such as children, disabled people, the elderly, prisoners, people in health or social care settings, addicts, or displaced persons – either contacted directly or via a gatekeeper (e.g. a service provider, care-giver, relative)?
- Does your project involve any risk to the participants’ health, or involve psychological stress, anxiety, physical pain or discomfort to the investigator and/or the participants?
- Does your project involve financial inducement offered to participants other than reasonable expenses and compensation for time?
- Does your project involve the collection of participants’ personal data other than gender, age and address; and have you ensured all reasonable steps are/will be taken to safeguard their anonymity?
- Does your project involve sensitive materials or topics that might be considered offensive, distressing, politically or socially sensitive, deeply personal or in breach of the law?
- Does your project have a detrimental impact on the environment, habitat, or species?